Comparing Myopia Treatments in Youth: Defocus Spectacles, Glasses, and Ortho-K

Официальное название

A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents

Обзор

The research project titled "A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents" aims to evaluate different non-surgical myopia correction methods in children. It focuses on assessing the impact of peripheral defocus spectacles, frame glasses, and orthokeratology lenses on the quality of life, clinical effectiveness, and costs associated with each method. The study is a prospective cohort study involving 90 children aged 8-17 years with myopia ranging from -1.00D to -6.00D. It aims to compare the psychological, social, and educational aspects of these correction methods, alongside their costs and clinical outcomes over a period of one year.

Подробное описание

The research project "Comparison of the clinical effect, quality of life and cost of using defocusing glasses, frame glasses and orthokeratology glasses in children and adolescents with myopia" aims to explore the impact of different myopia correction methods on children and adolescents. Myopia is one of the most common eye diseases in the world, especially in East Asia, where the incidence of myopia is extremely high. With the development of China's economy and the increasing pressure of children's education, the problem of myopia is becoming more and more serious, and parents and teenagers lack sufficient information and evidence for choosing the most suitable correction methods.

This study will compare the defocus frame glasses, ordinary monopteral frame glasses and orthokeratology glasses. The defocusing frame glasses are a new correction method, showing potential in controlling the length of the eye axis. Ordinary single-frame glasses are the most commonly used and economical choice; The orthokeratology lens is a kind of hard contact lens worn at night, which is in fast growing demand in the Chinese market.

The main objectives of the study include:

Quality of life assessment: To explore the impact of different correction methods on adolescents' daily life, learning, movement, appearance, mental health and social activities.

Use cost analysis: Compare the purchase cost, maintenance cost and replacement frequency of defocusing frame glasses, monopter frame glasses and orthokeratology glasses to assess the economic burden of long-term use.

In addition, the study will comprehensively evaluate the differences in clinical effectiveness, quality of life and cost of use of these correction methods, providing parents and adolescents with more comprehensive and objective information to help them make more informed choices.

Первичные конечные точки

• Improvement in Quality of Life Scores [Срок оценки: 1-Month Follow-up,6-Month Follow-up,12-Month Follow-up]
• Cost-Effectiveness Analysis [Срок оценки: 6-Month Follow-up,12-Month Follow-up]

Вторичные конечные точки (1)

• Clinical Effectiveness Analysis [Срок оценки: Baseline,6-Month Follow-up,12-Month Follow-up]

Критерии участия

Критерии включения

• Children aged 7-17 years.
• Myopia between -1.00D and -6.00D; astigmatism <±1.5D; best corrected visual acuity ≥1.0.
• First-time spectacle wearers who use a single correction method and meet the indications for it (any one of orthokeratology lenses, single-vision frame glasses, or myopia control frame glasses)
• Willing to participate in the entire research process and complete all the examinations, questionnaires and cost records as required.
• Be able to maintain contact throughout the research period, such as having a fixed address and contact information.

Критерии исключения

• History of strabismus, amblyopia, refractive disparity or retinal diseases
• Previous history of eye surgery
• Severe psychological disorders or behavioral problems
• History of allergy to contact lenses or contact lens care solutions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• HeEyeHospital — Шэньян

Публикации

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• Ma Y, Qu X, Zhu X, Xu X, Zhu J, Sankaridurg P, Lin S, Lu L, Zhao R, Wang L, Shi H, Tan H, You X, Yuan H, Sun S, Wang M, He X, Zou H, Congdon N. Age-Specific Prevalence of Visual Impairment and Refractive Error in Children Aged 3-10 Years in Shanghai, China. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6188-6196. doi: 10.1167/iovs.16-20243. PMID 27842160
• Pan CW, Ramamurthy D, Saw SM. Worldwide prevalence and risk factors for myopia. Ophthalmic Physiol Opt. 2012 Jan;32(1):3-16. doi: 10.1111/j.1475-1313.2011.00884.x. PMID 22150586
• Pan CW, Wu RK, Li J, Zhong H. Low prevalence of myopia among school children in rural China. BMC Ophthalmol. 2018 Jun 11;18(1):140. doi: 10.1186/s12886-018-0808-0. PMID 29890943
• Dolgin E. The myopia boom. Nature. 2015 Mar 19;519(7543):276-8. doi: 10.1038/519276a. No abstract available. PMID 25788077
• Li Y, Liu J, Qi P. The increasing prevalence of myopia in junior high school students in the Haidian District of Beijing, China: a 10-year population-based survey. BMC Ophthalmol. 2017 Jun 12;17(1):88. doi: 10.1186/s12886-017-0483-6. PMID 28606071
• Wang J, Ying GS, Fu X, Zhang R, Meng J, Gu F, Li J. Prevalence of myopia and vision impairment in school students in Eastern China. BMC Ophthalmol. 2020 Jan 2;20(1):2. doi: 10.1186/s12886-019-1281-0. PMID 31898504
• Wu PC, Huang HM, Yu HJ, Fang PC, Chen CT. Epidemiology of Myopia. Asia Pac J Ophthalmol (Phila). 2016 Nov/Dec;5(6):386-393. doi: 10.1097/APO.0000000000000236. PMID 27898441

Идентификаторы

NCT: NCT06278974 · PDSFGOCLMC-2023-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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